510(k) · Cleared
ClearedPeri-Loc Periarticular Locked Plating System for the Upper Extremity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 8, 2006 as substantially equivalent to K033669 (Smith & Nephew, Inc., 2003) and 1 other predicate after a 24-day review. Its family tree reaches back 7 generations to 1996. 108 later devices descend from it.
- Decided
- Jun 8, 2006
- Review
- 24 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962616 (1996). 28 ancestors in all, the oldest K890939 (1989). 108 later devices descend from it, 14 citing it directly.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 1 generation backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- This deviceK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 87 of its ownK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 77 of its ownK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 46 of its ownK132886 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · cites it directly · 41 of its ownK092015 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2009 · Recalled
- Descendant · cites it directly · 38 of its ownK100325 Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008 · cites it directly87descendants
- K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · cites it directly77descendants
- K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on46descendants
- K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2009 · cites it directly41descendants
- K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010 · cites it directly38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −1 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| +1 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| +1 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| +2 | K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +1 | K092015 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2009 | 1 |
| +1 | K100325 | Peri-Loc Locking Hole Inserts and Cable Accessories | Smith & Nephew, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 12 | 0 |
| 2024 | 14 | 0 |
| 2025 | 12 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 1…ns for use, material composition, and technological design characteristics. * Smith & Nephew Locked Plating System (PERI-LOCV Periarticular Locked Plating System) - K033669 * PERI-LOC Periarticular Locked Plating System for the Upper Extremity - K051735… | 2003 |
| * | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySummary page 1…, Locking and Non-locking Bone Screws, which are Une additions to and modifications to the PERI-LOC' Periarticular Locked Plating System devices previously cleared under K051735. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates, locking… | 2005 |
What descends from it? (108)
See all 10814 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | 2008 | 87 |
| K083032 | Peri-Loc Bone Plating and Screw System | 2009 | 77 |
| K092015 | Peri-Loc Periarticular Locked Plating System | 2009 | 41 |
| K100325 | Peri-Loc Locking Hole Inserts and Cable Accessories | 2010 | 38 |
| K081106 | Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the… | 2008 | 34 |
| K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | 2013 | 33 |
| K170887 | EVOS Small Fragment Plating System | 2017 | 13 |
| K100944 | Clavicle Locking Plate System | 2010 | 9 |
| K210837 | Smith & Nephew Plates and Screws | 2021 | 7 |
| K201918 | EVOS Large Fragment Plating System | 2020 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K082516 (Smith & Nephew, Inc., 2008) has gone furthest, with 87 descendants of its own.
- 27 other devices also cite its predicate K033669.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
Components in the PERI-LOC ° Periarticular Locked Plating System are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061352: Peri-Loc Periarticular Locked Plating System for the Upper Extremity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061352
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026